Shenzhen, CN · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Class II | Cardiovascular | 4 | 2026-05-14 |
| IRP | — | — | — | 1 | 2025-04-25 |
| FLL | Continuous Measurement Thermometer | Class II | General Hospital | 1 | 2020-10-07 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-14 | K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) | DXN | Class II | Cardiovascular |
| 2026-03-26 | K260273 | Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) | DXN | Class II | Cardiovascular |
| 2025-04-25 | K250046 | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) | IRP | — | — |
| 2025-02-21 | K243115 | Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) | DXN | Class II | Cardiovascular |
| 2024-10-24 | K241007 | Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) | DXN | Class II | Cardiovascular |
| 2020-10-07 | K200802 | Infrared Thermometer | FLL | Class II | General Hospital |